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Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 203 → 239 locations Eligibility criteria expanded, about 21 words · Secondary endpoints: details revised at 2 of 7 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 2 of 7 entries
  2. Primary completion pushed from Dec 31, 2027 to Mar 31, 2029 Enrollment increased: 674 → 1180 participants · Completion pushed from Dec 30, 2028 to Jul 30, 2033 · Trial arms changed: 2 → 4 · 4 morev6 Show 7 more changesShow less
    • Enrollment increased: 674 → 1180 participants
    • Completion pushed from Dec 30, 2028 to Jul 30, 2033
    • Trial arms changed: 2 → 4
    • Interventions: Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant (Drug), Arm B: Palbociclib or Ribociclib + Fulvestrant (Drug) to Arm A: Gedatolisib + Palbociclib + Fulvestrant (Drug), Arm B: Ribociclib + Fulvestrant (Drug), Arm C: Gedatolisib + Palbociclib + Letrozole…
    • Eligibility criteria expanded, about 78 words
    • Secondary endpoints: 8 to 7
    • Study description expanded, about 95 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv5
  4. Study sites: 188 to 203 Start date changed from estimate of Jun 30, 2025 to Jul 24, 2025v4 Show 1 more changeShow less
    • Start date changed from estimate of Jun 30, 2025 to Jul 24, 2025
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 188v3 Show 1 more changeShow less
    • Study sites: 0 to 188
  6. Eligibility criteria revisedv2 See this version in full on ClinicalTrials.gov ↗
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.
Trial Details
NCT Number NCT06757634
Lead Sponsor Celcuity Inc
Conditions Breast Cancer
Enrollment 1,180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov